Acetaminophen-induced Hepatotoxicity in Chronic Alcohol Abusers

NCT ID: NCT00137059

Last Updated: 2024-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-11-30
• Study Completion Date: 2005-05-31

Brief Summary

It is widely believed that people who abuse alcohol can sustain a liver injury after taking doses of acetaminophen just above the recommended maximum dose. This study is designed to look at the interaction between acetaminophen, liver injury and alcohol abuse. Subjects will undergo baseline tests to ensure that they do not have liver damage at the time of enrollment. Each subject will be randomly assigned to receive either a therapeutic dose of acetaminophen or a placebo three times a day for four days. Subjects will have blood work drawn on a daily basis to monitor the status of the liver. These tests will include conventional markers of liver injury in addition to a novel biomarker of liver function, a-GST. Previous work in the investigators' group has shown that a-GST is a more sensitive indicator of liver injury following acetaminophen overdose (Sivilotti 1999, Sivilotti 2002 x 2). However, it has never been used to study the alcoholic population. The investigators believe that a-GST may detect a subclinical acetaminophen-induced liver injury that has previously gone unrecognized in the alcoholic population.

Conditions

Hepatotoxicity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Interventions

acetaminophen sustained-release

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Individuals who self-report consuming at least 6 drinks per day, daily, for at least 6 weeks and who are currently enrolled at the Detoxification Center, Hotel Dieu Hospital.
• Last alcohol consumption occurring between 12 and 72 hours prior to screening for study.

Exclusion Criteria

• Individuals with a self-reported or previously documented history of hepatitis A, B, C or HIV.
• Individuals who have ingested any acetaminophen regardless of dose in the previous 48 hours.
• Individuals who have ingested > 4 grams of acetaminophen/day in any of the previous 7 days.
• Individuals < 18 years of age.
• Individuals with abnormal liver function at baseline (defined as AST or ALT > 120 IU/L, International Normalized Ratio [INR] > 1.5, and a-GST > 7.5 7 :g/L).
• Individuals who have an allergy or sensitivity to acetaminophen.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Marco L.A. Sivilotti

OTHER

Sponsor Role: lead

Responsible Party

Dr. Marco L.A. Sivilotti

Professor of Emergency Medicine, and of Biomedical & Molecular Science

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Marco LA Sivilotti, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

Queen's University

Kingston, Ontario, Canada

Countries

Canada

References

Bartels S, Sivilotti M, Crosby D, Richard J. Are recommended doses of acetaminophen hepatotoxic for recently abstinent alcoholics? A randomized trial. Clin Toxicol (Phila). 2008 Mar;46(3):243-9. doi: 10.1080/15563650701447020.

Reference Type: DERIVED

PMID: 18344107 (View on PubMed)

Other Identifiers

PSI R02-52

Identifier Type: -

Identifier Source: org_study_id